High-resolution Magnetic Resonance Imaging (MRI) Scans to Look for Spread of Melanoma to Nearby Lymph Nodes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Redwood Regional Medical Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Peter Brett, M.D., Redwood Regional Medical Group
ClinicalTrials.gov Identifier:
NCT00463892
First received: April 19, 2007
Last updated: July 30, 2012
Last verified: July 2012

April 19, 2007
July 30, 2012
June 2007
June 2013   (final data collection date for primary outcome measure)
Assessment of the sensitivity and specificity of high-resolution MRI scans of regional lymph nodes compared to results from regional lymph node biopsy. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Sensitivity and specificity of high-resolution MRI of regional lymph nodes in patients with primary melanoma compared to lymph node biopsy
Complete list of historical versions of study NCT00463892 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
High-resolution Magnetic Resonance Imaging (MRI) Scans to Look for Spread of Melanoma to Nearby Lymph Nodes
A Phase II Study of High-resolution Contrast-enhanced MRI of Regional Lymph Nodes in Patients With Clinically Localized Invasive Melanoma

The study is designed to see if a high-resolution MRI scan of lymph node areas near where a melanoma has been removed from the skin can pick up the spread of melanoma to those lymph nodes with a high degree of accuracy.

When a melanoma of the skin is diagnosed, there is some chance it can spread to nearby lymph nodes, and from there to other parts of the body. Currently, patients with melanoma at low risk for spreading to lymph nodes do not get the lymph nodes assessed except by a physical exam. Those at high risk for spreading to lymph nodes get one or more lymph nodes removed surgically to check for melanoma spread. But physical exam alone will often miss small areas of melanoma in lymph nodes; removal of lymph nodes by surgery is painful and can cause complications. Neither assessment tool is optimal.

This study is designed to see if use of very high-resolution contrast-enhanced MRI scans of lymph node areas near the primary melanoma site in the skin can accurately detect small areas of melanoma spread to those lymph nodes. If this turns out to be the case, in the future, MRI scans could potentially be an alternative for assessing lymph nodes, compared to physical exams alone or surgical removal of the lymph nodes.

In this study, patients with low risk melanoma will receive very high-resolution MRI scans of nearby lymph nodes every 6 months for 5 years of follow-up. If the MRI looks abnormal, the lymph nodes will be biopsied, and results from the biopsy compared to the results from the MRI.

Patients with high risk melanoma will get a baseline MRI of the nearby lymph nodes, and then one or more lymph nodes will be removed (usually by sentinel lymph node biopsy) regardless of the MRI results. Again, results from the biopsy will be compared to the results from the MRI. MRI's will still be repeated every 6 months to assess whether lymph nodes not removed at surgery develop any changes.

We plan to enroll 200 patients on this study and by the end of the study will have a measure of the sensitivity and specificity of high-resolution MRI scans in the detection of melanoma involvement of regional lymph nodes.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Melanoma
Procedure: High-resolution contrast-enhanced MRI scan
High-resolution contrast-enhanced MRI scan of regional lymph nodes every 6 months on study
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • history of invasive cutaneous melanoma stages 1-3 within 2 years of treatment of the melanoma by primary excision
  • eligible whether or not a sentinel lymph node biopsy or regional lymph node dissection has been performed
  • adequate renal function (creatinine 2 or less)
  • life expectancy 2 years of more

Exclusion Criteria:

  • history of severe claustrophobia precluding MRI scans
  • known hypersensitivity or other contraindication to gadolinium contrast
  • known presence of metastatic melanoma at sites beyond regional lymph nodes (stage 4)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00463892
RRMG #07-001
No
Peter Brett, M.D., Redwood Regional Medical Group
Redwood Regional Medical Group
Not Provided
Principal Investigator: Peter Brett, M.D. Redwood Regional Medical Group
Principal Investigator: David Feinberg, M.D., Ph.D. Redwood Regional Medical Group
Redwood Regional Medical Group
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP